Sabrina Cosmetics d/b/a SCOS – FDA Warning Letter, Jan 24, 2023
On October 28, 2022, the FDA issued a Warning Letter to Sabrina Cosmetics d/b/a SCOS, following a review of their website, https://sabrinacosmeticss.info. The FDA determined that the company was offering Electronic Nicotine Delivery Systems (ENDS) products for sale or distribution in the United States, which are classified as tobacco products under section 201(rr) of the FD&C Act.
The letter identified two primary violations. Firstly, the company's "Mixed Berry Bundle" product, containing a PUFF Plus Mixed Berries Disposable ENDS product, was found to be misbranded under section 903(a)(7)(B) of the FD&C Act. This is because the product was sold to an individual under the age of 21, violating section 906(d)(5) of the FD&C Act, which prohibits the sale of tobacco products to persons younger than 21.
Secondly, the "Mixed Berry Bundle" product was found to violate section 201(rr)(4) of the FD&C Act because it was marketed and co-packaged with cosmetic products (Max Makeup Cherimoya Lip Polish, Broadway Argan Oil Lip Gloss, and false eyelashes). This section prohibits marketing tobacco products in combination with any other FDA-regulated product.
Sabrina Cosmetics is required to submit a written response within 15 working days detailing
ID · 328192b7-a380-4864-b436-538915e8cee5
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